Allergy & Immunology
PHASE4
● Phase IV
Phase 4 trial compares LPV/r plus raltegravir versus LPV/r plus N(t)RTIs for HIV after first-line failure
ClinicalTrials.gov
Published March 30, 2026
Kirby Institute
NCT00931463 ↗
This was a phase 4 randomized controlled trial involving 558 HIV-infected subjects who experienced virological failure on a first-line antiretroviral regimen of two nucleoside/nucleotide reverse transcriptase inhibitors (N(t)RTIs) plus a non-nucleoside reverse transcriptase inhibitor (NNRTI). The study aimed to compare the virological efficacy of two second-line strategies: ritonavir-boosted lopinavir (LPV/r) combined with raltegravir versus LPV/r combined with 2-3 N(t)RTIs. The primary outcome was the proportion of participants achieving a plasma HIV RNA level below 200 copies/mL at 48 weeks after randomization, with a total follow-up period of 96 weeks.
The source text does not report any results for the primary efficacy outcome. No data on the number of participants achieving viral suppression, effect sizes, absolute numbers, or statistical significance (p-values or confidence intervals) are provided. Similarly, no secondary outcome data—including virological, immunological, safety, clinical, metabolic, adherence, resistance, or quality of life measures—are reported.
No safety or tolerability information is available from the source. The reported adverse events, serious adverse events, rates of discontinuation, and overall tolerability profiles for the compared regimens are not described. The study's limitations are not specified in the provided information.
The lead sponsor was the Kirby Institute. In the absence of reported efficacy and safety results, no conclusions can be drawn regarding the comparative clinical utility of LPV/r plus raltegravir versus LPV/r plus N(t)RTIs as a second-line strategy. Clinicians should await the publication of complete trial results before considering any practice implications from this study.
Researchers conducted a large, Phase 4 clinical trial to compare two different strategies for treating HIV when the first round of medication stops working. The study involved 558 people living with HIV who experienced this treatment failure. They were randomly assigned to receive one of two different second-line drug combinations to see which was more effective.
One group received a combination of two specific drugs, lopinavir/ritonavir and raltegravir. The other group received lopinavir/ritonavir plus a different set of two or three other standard drugs. The main goal was to see how many people in each group had their virus successfully suppressed to a very low level after 48 weeks of treatment.
The study also planned to look at safety, side effects, immune system changes, and quality of life over 96 weeks. However, the results for the primary goal of viral suppression, as well as all safety and secondary outcomes, have not been reported. Because no findings are available, it is impossible to say if one treatment strategy was better, safer, or more tolerable than the other. Readers should understand this is a description of a study that has been completed, but its results are not yet known.
What this means for you: A trial compared two HIV treatment plans, but no results on which worked better are available yet.
View Original Abstract ↓
Status: COMPLETED | Phase: PHASE4
Condition(s): HIV Infections
Intervention(s): raltegravir (DRUG), 2N(t)RTI (DRUG), Ritonavir-boosted lopinavir (DRUG)
The investigators hypothesize that following virological failure of a standard NNRTI+2N(T)RTI regimen second-line antiretroviral therapy consisting of ritonavir-boosted lopinavir and 2N(T)RTIs will offer comparable efficacy to that provided by ritonavir-boosted lopinavir and raltegravir.
The study will be conducted for 96-weeks with the primary endpoint analyzed after 48-weeks.
The primary endpoint is virological: a comparison of virological suppression in plasma \< 200 copies/mL between the randomized arms after 48 weeks.
Secondary and exploratory endpoints include virological, immunological, safety, clinical, metabolic, drug adherence, drug resistance and quality of life.
Detailed: In HIV-infected subjects who have virologically failed first-line antiretroviral therapy comprising 2N(t)RTI + NNRTI a regimen of second-line therapy incorporating ritonavir-boosted lopinavir and raltegravir provides comparable (i.e., non-inferior) antiretroviral efficacy over 48 weeks to a regimen containing ritonavir-boosted lopinavir and 2-3N(t)RTIs.
Eligible patients will be randomised to one of two arms:
I. ritonavir boosted lopinavir (LPV/r) 200mg/50mg 4 tabs once daily or 2 tabs twice daily + 2-3N(t)RTIs
II. ritonavir boosted lopinavir (LPV/r) 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400 mg twice daily
The primary objective of this study is to compare the virological efficacy of the two strategies as measured by the proportion of participants with HIV RNA
Primary Outcome(s): Participants With Plasma HIV RNA < 200 Copies/mL 48 Weeks After Randomization
Enrollment: 558 (ACTUAL)
Lead Sponsor: Kirby Institute
Start: 2009-09 | Primary Completion: 2012-09
Results posted: 2014-01-17
